The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients.

The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.

The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Lactose Powder; Drug: Probiotic Lactobacillus

Detailed Description

The patients are randomised to one of three treatment groups. Each comprising of 100 patients.

1. Standard therapy group. Patients will receive enteral feeding (with fibre) aiming at the target feeding rate that is determined by the treating physician and the ICU dietician, as is standard current practice. Two capsule containing placebo will be given 12 hourly via the feeding tube.
2. The first active treatment group, will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentum included in the feeding regime. Two capsules containing Lactobacillus fermentum (10 11 organisms per capsule) will be delivered via the feeding tube 12 hourly.
3. The second active treatment group will receive enteral feeding (with fibre) plus the probiotic Lactobacillus acidophilus included in the feeding regime. Two capsules containing Lactobacillus acidophilus (2x10 9 organisms per capsule) will be delivered via the feeding tube 12 hourly.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Intensive Care Unit Royal Melbourne Hospital Grattan Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours.
2. Patients who are commenced on enteral feeding via gastric or post pyloric routes.
3. Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study

Exclusion Criteria:

1. Patients less than 18 years old.
2. Patients who are already receiving probiotic treatment.
3. The lactobacillus acidophilus preparation to be used in the study, contains a very small amount of MSG (total dose of 20mg/day, equivalent to 10% of the initial dose used to test MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded.
4. Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As the Lactobacillus is a live micro-organism, immunosuppressed and pregnant pateints will be excluded.
5. Patients with a contra-indication to enteral feeding.
6. Patients with contra-indication to placement of enteral feeding tube.
7. Patients or next-of-kin who do not consent to inclusion in the study.
8. Patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard Care; Two capsules containing placebo will be given 12 hourly	Other: Lactose Powder
Active Comparator: First active treatment; Two capsules containing probiotic lactobacillus fermentin given 12 hourly	Drug: Probiotic Lactobacillus
Active Comparator: Second active reatment; Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly	Drug: Probiotic Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.	28 Days
To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.	28 days

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Megan Robertson, Intensive Care Unit, Royal Melbourne Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 17, 2005
• First Submitted That Met QC Criteria: November 17, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Nosocomial rates in critically ill patients
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Critical Illness
• Other Study ID Numbers: 2004.067